Back to search

Ireland· IE-PA-EU/1/12/760/001-002

Bronchitol 40 mg inhalation powder, hard capsules

A mannitol product containing mannitol, registered in Ireland by Pharmaxis Europe Limited. The same ATC class is registered in 11 of our 19 countries.

ATC R05CB16

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedBronchitol 40 mg inhalation powder, h…ATCR05CB16REGISTER NO.IE-PA-EU/1/12/760/001…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Mannitol is registered in 11 of 19 countries.

Countries holding a registration under ATC R05CB16 (mannitol), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose

Mannitol · ATC R05CB16

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Mannitol
Manufacturer
Pharmaxis Europe Limited
Country
Ireland (IE)
ATC code
R05CB16
ATC class
Mannitol
Defined daily dose
0.8 g, Inhal
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/12/760/001-002

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

304 interactions on record for mannitol.

Graded by severity as the source publishes them — 14 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Mannitol · interactions on record

304 records

  • 14 severe
  • 104 moderate
  • 5 minor
  • 181 info

Most severe, free to view

  • NeomycinA07AA01severe
  • StreptomycinA07AA04severe
  • KanamycinA07AA08severe
  • NeomycinB05CA09severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Mannitol in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mannitol products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Mannit Fresenius
  • Belgium · Mannitol Viaflo Baxter, Mannitol, Viaflo Baxter
  • Bulgaria · Манитол Б. Браун, Манитол Бакстер
  • Cyprus · Mannitol Demo, Mannitol Βιοσερ
  • Czechia · Ardeaosmosol Ma, Manitol Viaflo Baxter
  • Germany · Aridol, Mannit-Lösung Serag
  • Denmark · Mannitol Fresenius Kabi, Osmohale
  • Estonia · Mannitol Fresenius
  • Spain · Manitol Mein, Osmofundina
  • Finland · Aridol, Mannitol Braun
  • France · Mannitol Aguettant, Mannitol B. Braun
  • United Kingdom (Northern Ireland) · Mannitol Baxter Healthcare, Osmohale
  • Greece · Mannitol Bradex, Mannitol Cooper
  • Croatia · Manitol Hztm
  • Hungary · Mannisol A, Mannisol B
  • Iceland · Bronchitol, Mannitol Viaflo Baxter
  • Italy · Mannitolo Bioindustria L.I.M, Mannitolo Bioindustria L.I.M.
  • Liechtenstein · Bronchitol
  • Lithuania · Mannitol Fresenius
  • Luxembourg · Mannitol Viaflo, Mannitol Viaflo Baxter
  • Latvia · Mannitol Fresenius
  • Malta · Mannitol Baxter Holding, Mannitol Monico
  • Netherlands · Mannitol Baxter, Osmohale
  • Norway · Aridol, Bronchitol
  • Poland · Mannitol Baxter, Mannitol Fresenius
  • Portugal · Manitol Braun, Manitol Labesfal
  • Romania · Manitol Infomed Fluids, Mannitol Vioser
  • Sweden · Aridol, Mannitol Fresenius Kabi
  • Slovenia · Manitol Hztm
  • Slovakia · Infusio Mannitoli, Mannitol Bieffe

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/d43696d3-f9eb-4b7a-bc59-bf10cd3b61cf
GET /v1/drugs/d43696d3-f9eb-4b7a-bc59-bf10cd3b61cf?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "form": "Inhalation powder, hard capsule",
  "routes": [
    "Inhalation use"
  ],
  "source": "hpra",
  "atc_all": [
    "R05CB",
    "R05CB16"
  ],
  "strength": null,
  "pa_number": "EU/1/12/760/001-002",
  "substances": [
    "Mannitol"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "26/09/2012",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about mannitol.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.